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17 Berkeley Tech. L.J. 1265 (2002)
Innovation vs. Evasion: Clarifying Patent Rights in Second-Generation Genes and Proteins

handle is hein.journals/berktech17 and id is 1293 raw text is: INNOVATION VS. EVASION: CLARIFYING PATENT RIGHTS IN SECOND-GENERATION GENES AND PROTEINS Antony L Ryant and Roger G. Brookl ABSTRACT Protein engineering enables molecular biologists to create modified proteins with properties different from those found in nature. These second generation proteins present both promise and peril for the biotechnology industry. On the one hand, an increasing number of pharmaceutical products contain modified proteins, many with important clinical advantages. These innovative products should not be blocked by patents on the natural gene or protein. On the other hand, companies can now create modified proteins that behave no differently from the pat- ented analogs in their competitors' products. This threatens to make gene and protein patents so easy to evade as to render them almost meaning- less. This Article examines the patent-law question posed by protein engineering: do patents on genes and proteins cover second-generation analogs? Gene and protein patents are usually construed narrowly enough that infringement is governed by the doctrine of equivalents. Un- fortunately, the case law does not satisfactorily explain how to determine whether a modified gene or protein is equivalent to its natural analog. In this Article, the authors propose using the known inter- changeability test to analyze infringement by second-generation genes and proteins under the doctrine of equivalents. The known interchange- ability test, unlike alternatives such as the function-way-result test, is an objective measure of the functional similarities or differences between the patented and accused products. The authors contend that the known interchangeability test therefore strikes the right balance between innova- tion and evasion. TABLE OF CONTENTS IN TRODU CTION ..................................................................................................... 1266 II. B A CKGROUN D ...................................................................................................... 1269 © 2002 Antony L. Ryan and Roger G. Brooks t Partner, Cravath, Swaine & Moore. Partner, Cravath, Swaine & Moore.

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